The European Commission has approved Tivicay (dolutegravir) made by Viiv Healthcare for use in combination with other anti-retroviral medicinal products for the treatment of HIV.
The Tivicay clinical development program included people living with HIV who were new to treatment (naive), as well as those who had already been treated with other HIV medicines (experienced) and those who were infected with a virus that had developed resistance to previously available integrase inhibitors. The submission supporting the approval included data from four pivotal Phase III clinical trials in which 2,557 adults received treatment with Tivicay or a comparator. The submission also included data from a fifth study in children aged 12 years and older.
New treatment option for HIV
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